title: Cotrimoxazole prophylaxis and risk of severe anemia or severe neutropenia in HAART-exposed, HIV-uninfected infants.
abstract: BACKGROUND
  Prophylactic cotrimoxazole is recommended for infants born to HIV-infected mothers. However, cotrimoxazole may increase the risk of severe anemia or neutropenia.
  
  
  METHODS
  We compared the proportion of HIV-exposed uninfected (HIV-EU) infants experiencing incident severe anemia (and separately, severe neutropenia) between a prospective cohort receiving prophylactic cotrimoxazole from 1 to 6 months vs. infants from two prior trials who did not receive cotrimoxazole. Infants were from rural and urban communities in southern Botswana.
  
  
  RESULTS
  A total of 1705 HIV-EU infants were included. Among these 645 (37.8%) were fed with iron-supplemented formula from birth. Severe anemia developed in 87 (5.1%) infants, and severe neutropenia in 164 (9.6%) infants. In an analysis stratified by infant feeding method, there were no significant differences in the risk of severe anemia by prophylactic cotrimoxazole exposure-risk difference, -0.69% (95% confidence interval [CI] -2.1 to 0.76%). Findings were similar in multivariable analysis, adjusted odds ratio (aOR) 0.35 (95% CI 0.07 to 1.65). There were also no significant differences observed for severe neutropenia by cotrimoxazole exposure, risk difference 2.0% (95% CI -1.3 to 5.2%) and aOR 0.80 (95% CI 0.33 to 1.93).
  
  
  CONCLUSIONS
  Severe anemia and severe neutropenia were infrequent among HIV-exposed uninfected infants receiving cotrimoxazole from 1-6 months of age. Concerns regarding hematologic toxicity should not limit the use of prophylactic cotrimoxazole in HIV-exposed uninfected infants. CLINICALTRIAL.SGOV REGISTRATION NUMBERS: NCT01086878 (http://clinicaltrials.gov/show/NCT01086878), NCT00197587 (http://clinicaltrials.gov/show/NCT00197587), and NCT00270296 (http://clinicaltrials.gov/show/NCT00270296).
authors.affiliation: Division of Infectious Diseases, Brigham and Women's Hospital, Boston, Massachusetts, United States of America ; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana ; Department of Immunology and Infectious Diseases, Harvard School of Public Health, Boston, Massachusetts, United States of America.
authors.forename: Scott
authors.initials: S
authors.lastname: Dryden-Peterson
authors.forename: Oluwemimo
authors.initials: O
authors.lastname: Jayeoba
authors.forename: Michael D
authors.initials: MD
authors.lastname: Hughes
authors.forename: Haruna
authors.initials: H
authors.lastname: Jibril
authors.forename: Kenneth
authors.initials: K
authors.lastname: McIntosh
authors.forename: Taolo A
authors.initials: TA
authors.lastname: Modise
authors.forename: Aida
authors.initials: A
authors.lastname: Asmelash
authors.forename: Kathleen M
authors.initials: KM
authors.lastname: Powis
authors.forename: Max
authors.initials: M
authors.lastname: Essex
authors.forename: Roger L
authors.initials: RL
authors.lastname: Shapiro
authors.forename: Shahin
authors.initials: S
authors.lastname: Lockman
mesh_terms: D000740:Anemia / Q000139:chemically induced*; D000890:Anti-Infective Agents / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects*; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D007223:Infant; D009503:Neutropenia / Q000139:chemically induced*; D011446:Prospective Studies; D015662:Trimethoprim, Sulfamethoxazole Drug Combination / Q000627:therapeutic use*
chemical_list: D000890:Anti-Infective Agents; D015662:Trimethoprim, Sulfamethoxazole Drug Combination